Avastin for Wet Macular Degeneration – Off Label Usage

Avastin (bevacizumab) has become a drug of choice by some opthalmologists for a treatment of wet macular degeneration. Genetech, the company that produces Avastin, would prefer that Lucentis be used even though doctors consider both drugs equivalent treatment for this eye disease. Yet, Avastin continues to be used as a treatment of macular degeneration, even though it has no FDA approval for such use.

With the two drugs being considered equivalent, one must wonder why a drug manufacturer would want doctors to use Lucentis when it costs approximately 40 – 50 times as much as Avastin.

Avastin works by inhibiting the growth of abnormal blood vessels in the retina. The growth of these blood vessels indicates that a person is suffering from wet macular degeneration. Researchers at the University of Miami’s Bascom Palmer Eye Institute demonstrated that Avastin substantially reduced the leakage in these blood vessels. This halted the progression of and in some cases reversed the damage caused by wet macular degeneration.

However Genentech, the company that produces Avastin, is concerned with the potential adverse effects of the drug if it is used to treat wet macular degeneration. The use of the drug to treat this eye disease is considered off-label and even though it has become a widespread treatment for macular degeneration, Genentech continues to promote it’s more costly drug Lucentis (ranibizumab). A single treatment of Lucentis can cost approximately $2,000 for a single treatment, while a single treatment of Avastin would cost approximately $50.

In May 2007 British researchers published a cost analysis comparting the use of Lucentis and Avastin to treat macular degeneration. The study was published in the British Journal of Opthalmology and in it, researchers concluded that Lucentis would have to be 2.5 times as effective in treating macular degeneration to justify the additional costs being charged for the drug. Researchers indicated that Lucentis when compared to Avastin, does not appear to be as cost-effective.

In October 2007 the company that makes both Lucentis and Avastin announced a strategy that would limit the availability of Avastin for ocular uses such as treatment of macular degeneration. This strategy was to kick in as of January 1, 2008 and the reason for this according to GenenTech was due to safety concerns when Avastin was divided into smaller quanities need for injection into the eye.

GenenTech later responded to widespread protests from eye doctors and organizations, including the American Academy of Ophthalmology (AAO) by announcing that Avastin would still be sold directly to physicians and delivered to destinations of their choice, including pharmacies used at dividing the drug.

In November 2007, an emotionally charged AAO conference session seen eye doctors protesting the original decision that would have seen supplies of Avastin used to treat wet macular degeneration deprived from low income individuals. Genentech responded by saying it would not interfere with doctors who elected to prescribe Avastin for ophthalmic uses.

In the past, serious safety concerns were expressed about the off-label use of Avastin as a macular degeneration treatment. The FDA in 2005 warned that Avastin when used to treat colon cancer and other cancers, could significantly increase the risk of stroke, heart attack and other related adverse health events. However, the British Journal of Ophthalmology in July 2006 published results of one internet survey among eye doctors where no adverse health side effects were shown when Avastin was used to treat macular degeneration.

The reason given for these results seemingly came from the low doses of the drug used when injected into the eye to treat this eye disease. Other researchers did indicate that the long-term safety risks of off-label Avastin use in the eye remain unknown. When used to treat cancer, higher doses of Avastin are used and the drug is administered through an intravenous, differing from the injection required to treat the eye disease macular degeneration.

One must truly wonder if this is about saving a persons sight or if it is more about making money. There is little doubt that when presented with the options of treatments for macular degeneration that cost 40 – 50 times more than Avastin, those patients who suffer from this eye disease will opt for the less expensive treatment. Most patients diagnosed with wet macular degeneration are elderly on fixed incomes and possess little or no medical insurance.

Many state run health plans do not cover the costs of either Lucentis or Avastin, leaving patients in a vulnerable state where they have to choose saving their sight or spending what little savings they have. For many, the choice is obvious and they elect to be treated with Avastin, even though this use is considered off-label for the eye disease.

With more research taking place into the effectiveness and safety of Avastin when used to treat macular degeneration, both patients and doctors will be given more information from which they can make the right decision for their treatments.